R-ICE and High-Dose Cyclophosphamide With PET/CT for Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT00809341
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — BIOLOGICAL
    375 mg/m\^2 on Day 1 of each cycle as part of R-CHOP or R-ICE. Also given 375 mg/m\^2 on Days 1, 30, and 37 as part of HiCy.
  • Cyclophosphamide — DRUG
    750 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.
  • Doxorubicin — DRUG
    50 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.
  • Vincristine — DRUG
    1.4 mg/m\^2 on Day 1 of each cycle as part of R-CHOP.
  • Prednisone — DRUG
    100 mg/day on Days 1-5 of each cycle as part of R-CHOP.
  • Ifosfamide — DRUG
    2000 mg/m\^2/day on Days 1-3 of each cycle as part of R-CHOP.
  • Carboplatin — DRUG
    Given on Day 2 of each cycle as part of R-CHOP. Dosed according to renal function.
  • Etoposide — DRUG
    100 mg/m\^2/day on Days 1-3 of each cycle as part of R-CHOP.
  • High-dose cyclophosphamide — DRUG
    50 mg/kg/day on Days 2-5 of HiCy.
  • PET scan — PROCEDURE
    Performed once between Days 16-20 of cycle 3 of R-CHOP.

Study Details

This research is being done to see if a PET scan that is obtained after 3 cycles of a standard chemotherapy regimen can help guide treatment for patients with a blood disease called Non-Hodgkin's Lymphoma. The standard treatment for newly diagnosed lymphoma is 6 to 8 cycles of chemotherapy like the CHOP combination (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). This regimen can cure about half of patients with lymphoma, but in many others disease relapses (comes back). Relapses are generally treated with more chemotherapy. We believe that a PET scan (a type of imaging study that "lights up" in areas of cells with high activity such as lymphoma), may identify patients early who are at high risk of relapse. The purpose of this research study is to find out if people whose treatment is changed early to an intensification regimen (high dose chemotherapy) based on a positive PET scan will have longer remissions than they would if they did not receive that high dose chemotherapy.

Key Dates

Start date
Jan 31, 2009
Status verified
Sep 2018
Primary completion
Apr 30, 2014
Completion
Apr 30, 2014

Study Design

Enrollment
27 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: PET Negative
    R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) or an equivalent anthracycline-containing regimen for 3 cycles, followed by PET scan. Participants with a negative PET scan will complete their chemotherapy regimen as prescribed by their oncologist.
  • Active Comparator: PET Positive
    R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) or an equivalent anthracycline-containing regimen for 3 cycles, followed by PET scan. Participants with a positive PET scan will receive two cycles of R-ICE (rituximab, ifosfamide, carboplatin, etoposide) followed by HiCy (high-dose cyclophosphamide).

Primary Outcome Measure

Event-free Survival in Patient Receiving Early Treatment Intensification Based on a Positive Mid-treatment PET Scan [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21231-

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By research site
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins· Baltimore, MD

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